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Figure 6.36 Balanced frequency divider-by-two
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Establishing and maintaining an effective QMS, as this chapter describes, requires a signi cant cultural shift. Many employees and functional management will nd the business transformation of de ning processes, assigning ownership, delegating authority, and responsibility for process performance within the QMS is a signi cant change in business conduct. The most signi cant change results from the shift of control in process expertise and decision-making authority from functional management to process owner. Signi cant business transformation may result by assigning responsibility and accountability to the process owner, and management s support of process owners who drive continuous process improvement. In The Second American Revolution, Rockefeller describes the conservatism of organizations: An organization is a system, with a logic of its own, and all the weight of tradition and inertia. The deck is stacked in favor of the tried and proven way of doing things and against the taking of risks and striking out in new directions [9]. If an organization is not already practicing principles of delegation, process ownership, established metric collection, management review, and continuous improvement, barriers within the organization will need to be addressed and broken down in order to establish new behaviors. These barriers to change will exist within and between functions, functional management and staff, and possibly between companies and regulators.
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P1: KOA WY050-04 WY050-Ulick-v4 September 19, 2004 11:4
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FIGURE 4 Kinetics of accumulation of triglyceride hydroperoxide in Intralipid exposed to phototherapy light under conditions that mimic the situation in an NICU (neonatal intensive care unit). A solution of 20% Intralipid was dispensed into a glass reservoir containing plastic tubing (line 3), with aluminum foil (line 4), or a plastic reservoir after supplementation with 1 mmol/L sodium ascorbate (line 5) and exposed to phototherapy light for up to 24 h. For all samples the light uxes measured were 11.7 25.9 W/cm2 per nanometer for 24 h. At the time points indicated, aliquots were withdrawn, extracted, and their hexane extracts analyzed for the presence of triglyceride hydroperoxides and -tocopherol as described in the methods section [19].
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Endotoxin testing, LAL, according to Eur. Pharm. 2.6.14 and Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drug, Biological Products and Medical Devices, 1987, Sections I IV, http://www.fda.gov/cber/gdlns/lal.pdf.
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